RecruitingNot ApplicableNCT07129551

Navigation, Outcomes and Quality-of-life in Prostate Cancer Patients Undergoing PSMA-targeted Surgery


Sponsor

Martini-Klinik am UKE GmbH

Enrollment

102 participants

Start Date

Jan 21, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

As part of a feasibility study, it's planned to use a 3D virtual mixed reality model with prostate cancer patients who show signs of lymph node metastasis and are scheduled for surgery. The model is based on PSMA PET imaging performed prior to surgery and will be evaluated by surgeons, the surgical team, and patients as part of the consultation process. First, the researcher investigates whether the removal of lymph node metastases has improved compared to the data in the literature . In addition, the study examines how the 3D model influences the movement of surgical instruments and the efficiency of surgical removal of lymph node metastases. To this end, the analyzed recorded video and position data of the instruments used during procedures performed with a surgical robot. It's also an aim to develop two methods-using landmarks and visual position tracking-for more targeted navigation during surgery. Additionally, short-term results examine, such as PSA response rates, as an indication of successful lymph node metastasis removal and patient quality of life.


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 78 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a special dye — visible under a specific light during surgery — can help surgeons more precisely remove cancerous lymph nodes in prostate cancer patients, guided by a scan called PSMA-PET. **You may be eligible if (Cohort A — first surgery)...** - You have hormone-sensitive prostate cancer - You are scheduled for surgical removal of the prostate and nearby lymph nodes - Fewer than 3 lymph nodes show cancer on a PSMA-PET scan **You may be eligible if (Cohort B — recurrence after surgery)...** - Your prostate cancer has come back after a prior prostatectomy - You are planned for a salvage lymph node removal - Your PSA level is below 2 ng/mL and fewer than 3 lymph nodes are affected on a PSMA-PET scan **You may NOT be eligible if...** - Your life expectancy is less than 10 years - You have a medical reason that prevents surgery - You received hormone therapy (ADT) within the past 3 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREpreop virtual 3D model

Cohort A: Radical prostatectomy with PSMA-targeted lymph node dissection (separate specimen) and bilateral extended pelvic lymph node dissection with additional use of a virtual 3D-model (of preoperative PSMA-PET examination) prior to surgery and postoperatively; Cohort B: Salvage lymph node dissection with PSMA-targeted lymph node dissection (separate specimen) and at least ipsilateral pelvic template lymph node dissection with additional use of a virtual 3D-model (of preoperative PSMA-PET examination) prior to surgery and postoperatively

PROCEDUREpostop 3D model

Cohort A: Radical prostatectomy with PSMA-targeted lymph node dissection (separate specimen) and bilateral extended pelvic lymph node dissection with use of standard PSMA-PET examination prior to surgery; only postoperatively a virtual 3D-model (of preoperative PSMA-PET examination) will be evaluated; Cohort B: Salvage lymph node dissection with PSMA-targeted lymph node dissection (separate specimen) and at least ipsilateral pelvic template lymph node dissection with use of standard PSMA-PET examination prior to surgery; only postoperatively a virtual 3D-model (of preoperative PSMA-PET examination) will be evaluated


Locations(2)

Martini-Klinik

Hamburg, Free and Hanseatic City of Hamburg, Germany

Anke Renter

Hamburg, Free and Hanseatic City of Hamburg, Germany

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07129551


Related Trials